DIGITAL ECG HOLTER RECORDER, MODEL DR512— 510(k) K982975

Substantially Equivalent

Datrix

FDA 510(k) clearance K982975 for DIGITAL ECG HOLTER RECORDER, MODEL DR512, Substantially Equivalent on 1998-11-10. Applicant: Datrix.

Clearance details

Applicant: Datrix
Product code: Code MWJ
Advisory panel: Cardiovascular
Date received: 1998-08-26
Decision date: 1998-11-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Escondido, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MWJ

product code MWJ

Other: 1
Total: 1

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.